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Bionano Genomics Obtains China NMPA Approval for DNA Extraction, Labeling Products

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NEW YORK – Bionano Genomics' Chinese original equipment manufacturing (OEM) partner, Beijing Genome Precision Technology (BGPT), has obtained reagent class I registrations from China's National Medical Products Administration (NMPA) for Bionano's DNA extraction kit and labeling products, GenomeWeb has learned.

At Bionano's inaugural strategy day in New York on Thursday, the San Diego-based optical genome mapping (OGM) company said that the NMPA registrations, for its bone marrow aspirate (BMA) DNA isolation kit and its direct label and stain (DLS) DNA labeling kit, enable these reagents to be used for in vitro diagnostics in China.

The approvals enable Bionano’s reagents to be used for clinical applications in China, the company noted. Eventually, they are expected to help sales and placements of both the company’s instruments and reagents in China.

According to the NMPA database, the agency issued three approvals to BGPT on Dec. 29, 2022: two for DNA staining and one for DNA isolation and purification.

Headquartered in Beijing, BGPT is “a comprehensive molecular diagnostics enterprise integrating R&D, manufacture, distribution, registration, and services,” according to the firm’s website. Besides Bionano, the company also counts Agilent Technologies and Thermo Fisher Scientific among its partners.

Bionano President and CEO Erik Holmlin told GenomeWeb that the company has been working with BGPT since early 2022. It is unclear, though, whether BGPT is Bionano's only OEM partner in China.

"We are really excited to see the progress and the milestones we reached in China," Holmlin told GenomeWeb. "The OEM project makes optical genome mapping available in China for labs who want to run it and get the critical information they need."

Holmlin added that Bionano also aims for its Saphyr system to obtain NMPA approval, further driving the company’s OGM technology for clinical adoption in China.

In addition to its OEM partner, Bionano already has a team of local staff in China and has been actively forging collaborations with key opinion leaders in the country to gain recognition and endorsements for its technology.

Beyond China, Holmlin told investors during the event, the company is collaborating with clinicians in India as part of its mission to expand further into the Asia-Pacific market.

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